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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSVS APEX APEX EXIMER LASER WORKSTATION
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
Alcon Laboratories, Inc.
2501 discovery drive,suite 500
orlando, FL 32826-3714
PMA NumberP930034
Supplement NumberS006
Date Received06/24/1996
Decision Date10/22/1996
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR DISCONTINUING FURTHER FOLLOW-UP AND REPORT OF THE <6.0 MM SUBJECTS IN ACCORDANCE WITH THE POST APPROVAL REQUIREMENTS
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